Public trial
RBR-6vbgvqh Treating Shoulder Pain: Corticosteroid Injection vs. Phenol Injection
Date of registration: 04/20/2022 (mm/dd/yyyy)Last approval date : 04/20/2022 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Acromioclavicular joint pain: Intra-articular Corticosteroid Injection versus Neurolysis of the acromial branches of the suprascapular and lateral pectoral nerves with 5% Phenol
pt-br
Dor na articulação acromioclavicular: Injeção Intra-articular de Corticosteroide versus Neurólise dos ramos acromiais dos nervos supraescapular e peitoral lateral com Fenol 5%
es
Acromioclavicular joint pain: Intra-articular Corticosteroid Injection versus Neurolysis of the acromial branches of the suprascapular and lateral pectoral nerves with 5% Phenol
Trial identification
- UTN code: U1111-1277-3928
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Public title:
en
Treating Shoulder Pain: Corticosteroid Injection vs. Phenol Injection
pt-br
Tratando dor no ombro: Injeção de Corticoide versus Injeção de Fenol
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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48383721.5.0000.5463
Issuing authority: Plataforma Brasil
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4.858.322
Issuing authority: Comitê de Ética em Pesquisa Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE
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48383721.5.0000.5463
Sponsors
- Primary sponsor: Gilson Carone Neto
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Secondary sponsor:
- Institution: Hospital do Servidor Público Estadual de São Paulo
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Supporting source:
- Institution: Gilson Carone Neto
- Institution: Hospital do Servidor Público Estadual de São Paulo
Health conditions
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Health conditions:
en
Osteoarthritis; Shoulder Pain
pt-br
Osteoartrite; Dor de Ombro
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General descriptors for health conditions:
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A02.835.583.032 Acromioclavicular Joint
pt-br
A02.835.583.032 Articulação Acromioclavicular
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Specific descriptors:
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C05.550.114.606 Osteoarthritis
pt-br
C05.550.114.606 Osteoartrite
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C05.550.091.700 Shoulder Pain
pt-br
C05.550.091.700 Dor de Ombro
Interventions
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Interventions:
en
This is a clinical trial of intervention, prospective, controlled, randomized, blinded for the evaluator, comparing the effect of intra-articular injection of corticosteroid versus neurolysis of the acromial branches of the suprascapular and lateral pectoral nerves with 5% phenol. The experimental group consists of 25 patients with chronic pain in the acromioclavicular joint who will undergo neurolysis of the acromial branches of the lateral pectoral and suprascapular cutaneous nerve. The control group is composed of 25 patients who will undergo intra-articular corticosteroid injection into the acromioclavicular joint. The duration of the intervention will be 6 months.
pt-br
Trata-se de ensaio clínico de intervenção, prospectivo, controlado, aleatorizado, encoberto para o avaliador, comparando o efeito da injeção intra-articular de corticosteroide versus neurólise dos ramos acromiais dos nervos supraescapular e peitoral lateral com fenol 5%. O grupo experimental compõe-se de 25 pacientes com dor crônica na articulação acromioclavicular que serão submetidos a neurólise dos ramos acromiais do nervo cutâneo peitoral lateral e supraescapular. O grupo controle compõe-se de 25 pacientes que serão submetidos a infiltração intra-articular de corticosteroide na articulação acromioclavicular. A duração da intervenção será de 6 meses.
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Descriptors:
en
E03.155.086.711 Nerve Block
pt-br
E03.155.086.711 Bloqueio Nervoso
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E02.319.267.530.380 Injections, Intra-Articular
pt-br
E02.319.267.530.380 Injeções Intra-Articulares
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 09/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 50 - 18 Y 0 -
Inclusion criteria:
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Male and female patients; over 18 years old; with pain in the acromioclavicular joint (for more than a month); with moderate or severe chronic joint pain (VAS equal to or greater than 4).
pt-br
Pacientes de sexo masculino e sexo feminino; maiores de 18 anos; com dor na articulação acromioclavicular (há mais de um mês); que tenham dor articular crônica moderada ou intensa (EVA igual ou maior que 4).
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Exclusion criteria:
en
Patients with contraindications to the procedure: blood dyscrasia; refusal of the procedure; infection at the puncture site; patients with any other shoulder dysfunction that may confound the diagnosis such as advanced osteoarthritis of the glenohumeral joint, or adhesive capsulitis; patients with cognitive impairment or psychiatric disorder; allergic to lidocaine, methylprednisolone and phenol; pregnant women; patients with complete loss of joint space on ultrasound examination.
pt-br
Pacientes com contraindicações a realização do procedimento: discrasia sanguínea; recusa do procedimento; infecção no local de punção; pacientes com alguma outra disfunção no ombro que possam confundir o diagnóstico como osteoatrite avançada da articulação glenoumeral ou capsulite adesiva; pacientes com transtorno cognitivo ou distúrbio psiquiátrico; alérgicos a lidocaína, metilprednisolona e fenol;gestantes; pacientes com perda completa do espaço articular ao exame ultrassonográfico.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 2 Double-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
To evaluate the efficacy of neurolysis with 5% phenol in the treatment of pain in patients with acromioclavicular joint pain compared with intra-articular corticosteroid injection.
pt-br
Avaliar a eficácia da neurólise com fenol 5% no tratamento da dor em pacientes portadores de dor na articulação acrômioclavicular comparado com injeção intra-articular de corticosteroide.
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Secondary outcomes:
en
To verify if there is superiority of neurolysis over intra-articular corticosteroid injection to improve joint pain
pt-br
Verificar se há superioridade da neurólise sobre a injeção intra-articular de corticosteroide para a melhora da dor na articulação
en
Assess pain over a 6-month period, through the numerical verbal pain scale and ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form) questionnaire: pre-procedure, 1 hour after the procedure, after 1 week, 1 month, 3 and 6 months;
pt-br
Avaliar a dor ao longo de 6 meses, através da escala verbal numérica de dor e questionário ASES (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form): pré-procedimento, 1 hora após o procedimento, após 1 semana, 1 mês, 3 e 6 meses;
Contacts
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Public contact
- Full name: Gilson Carone Neto
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- Address: Rua Pedro de Toledo, 1800
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: +551145738000
- Email: gilsoncarone@hotmail.com
- Affiliation: Hospital do Servidor Público Estadual de São Paulo
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Scientific contact
- Full name: Gilson Carone Neto
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- Address: Rua Pedro de Toledo, 1800
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: +551145738000
- Email: gilsoncarone@hotmail.com
- Affiliation: Hospital do Servidor Público Estadual de São Paulo
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Site contact
- Full name: Gilson Carone Neto
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- Address: Rua Pedro de Toledo, 1800
- City: São Paulo / Brazil
- Zip code: 04039-000
- Phone: +551145738000
- Email: gilsoncarone@hotmail.com
- Affiliation: Hospital do Servidor Público Estadual de São Paulo
Additional links:
Total de Ensaios Clínicos 16961.
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